Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Perennial Allergic Rhinitis

Primary Objective:

- To evaluate safety (4 weeks)

Secondary Objectives:

• To evaluate the long-term safety (12 weeks)
• To evaluate the efficacy
• To characterize the pharmacokinetic profile

Study Overview

• Status: Completed
• Conditions: Rhinitis Perennial
• Intervention / Treatment: Drug: fexofenadine/Allegra (M016455)

Detailed Description

The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392015
  • Kanazawa-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392012
  • Kawaguchi-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392001
  • Kawasaki-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392003
  • Kawasaki-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392004
  • Kita-Ku, Japan
    • Sanofi-Aventis Investigational Site Number 392002
  • Kofu-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392011
  • Obu-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392014
  • Seki-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392013
  • Yokohama-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392005
  • Yokohama-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392006
  • Yokohama-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392007
  • Yokohama-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392008
  • Yokohama-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392009
  • Yokohama-Shi, Japan
    • Sanofi-Aventis Investigational Site Number 392010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Aged 6 months through 11 years
• Patients with perennial allergic rhinitis

Exclusion criteria:

• Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy.
• Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4.
• Patients with vasomotor rhinitis or eosinophilic rhinitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Age 6 months - 2 years; Patients between 6 months and 2 years old	Drug: fexofenadine/Allegra (M016455); Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral
Experimental: Age 2 - 11 years; Patients between 2 and 11 years (and under 10.5 kg)	Drug: fexofenadine/Allegra (M016455); Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral
Experimental: Age 2 - 11 years (and over 10.5 kg); Patients between 2 and 11 years (and over 10.5 kg)	Drug: fexofenadine/Allegra (M016455); Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	4 weeks
The number of clinically significant abnormalities for laboratory findings	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	12 weeks
The number of clinically significant abnormalities for laboratory findings	12 weeks
Changes from baseline in nasal symptom scores on patient diary	4 weeks
Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator	week 2 and 4
Pharmacokinetic parameters of fexofenadine at steady state; AUC	week 4 and 12

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 12, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Fexofenadine
• Other Study ID Numbers: SFY10717; U1111-1115-3842 (Other Identifier: UTN)